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Based on record review and interviews with hospital staff, the governing body failed to ensure quality of care and hospital operations are conducted in safe manner.

Findings:

1. The hospital's governing body failed to ensure each patients' rights are protected and all requirements are met. See A Tags 0115, 0118, 0119, 0120, 0121, 0122, 0123, 0144, 0145, 0154, 0164 0168, and 0194.

2. The hospital's governing body failed to ensure the hospital is constructed, arranged and maintained to ensure the safety of the patients. See A Tags 0700, 0701, 0702, 0709, 0710, 0713, 0722, 0723, 0724 and 0726.

3. The hospital's governing body failed to ensure an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff is maintained. See A Tags 0747, 0748, 0749 and 0756.

4. The hospital's governing body failed ensure a discharge planning process to ensure all patients were appropriately discharged with needs assessment, interventions, teaching and follow-up care to minimize the likelihood of having any patient rehospitalized for reasons that could have been prevented is developed and implemented. See A Tag 0799.

5. The hospital's governing body failed to ensure surgical services provided are well organized and provided in accordance with acceptable standards of practice and are in compliance with all the requirements of this Condition of Participation. See A Tags 0940, 0941, 0942, 0943, 0944, 0945, 0951, 0956, 0957, and 0958.

6. The hospital's governing body failed to ensure the hospital has an effective discharge planning process for all patients. See A Tag 0799.

Based on record review and interviews with hospital staff, the governing body failed to ensure that personnel providing services by contract are oriented, trained and evaluated to ensure competence and meet the same health requirements as employees of the hospital.

Findings:

On 9/25/13 in the afternoon Staff C stated consultant dietician services are provided by a contract with Staff Q.

Review of the dietician report listed Staff R as the consultant dietician, this was confirmed by Staff B on 9/26/13.

On 9/26/13 Staff C and B were both asked for the health, education and training files for Staff Q and R. None was provided.

Based on document review, policy and procedure review and staff interview, it was determined the hospital failed to:

a. provide an established and approved process for the management of patient complaints and grievances. See Tag A-0118;

b. ensure the Governing Body approved the complaint and grievance process. See Tag A-0119;

c. develop a process to notify patients/patients' representatives of the right for referral to the Quality Improvement Organization (QIO), the Oklahoma Foundation for Medical Quality, for concerns regarding care or early hospital discharge. See Tag A-0120;

d. ensure the process for submitting a complaint or grievance was clearly defined for the patient. See Tag A-0121;

e. ensure the grievance process had specific time frames for review of the grievance and provision of a response. See Tag A-0122;

f. ensure that the patient was given a written notice in response to a grievance to include the steps taken to investigate the issue and the results of the process. See Tag A-0123;

g. ensure care was provided in a safe setting. See Tag A-0144;

h. develop and implement an effective policy to protect and prevent patient abuse by staff. See Tag A-0145;

i. develop and implement an effective policy for the use of restraints and seclusion. See Tag A-0154;

j. ensure the use of less restrictive interventions prior to the placement of restraints. See Tag A-0164;

k. obtain a physician's order before the use of restraints as an intervention. See Tag A-0168; and

l. failed to ensure the staff had proper training on the use of restraints. See Tag A-0194.

Based on policy and procedure review, hospital document review and staff interview, it was determined the hospital failed to:
a. ensure complaints and grievances were appropriately identified;
b. develop and implement a grievance policy according to the requirements; and
c. failed to inform patients/representatives of the grievance process.
Findings:
On the morning of 09/25/13, the surveyors requested to review the hospital's complaints and grievances for 2013. A binder, titled, "Incidents and Grievances 2013" was provided. The binder included three forms: Emergency Department High Risk Post Discharge Follow Up Form, Incident/Variance Report, and Situation Report.
The documentation in the binder did not clearly identify what was a identified as a grievance versus what was identified as an incident or as a complaint. There was no documentation of investigation for any of the events recorded in the binder.
The surveyors requested the policy for patient grievances. The hospital provided a policy titled, "Grievance Procedure." The policy referred to employee grievances. The policy did not contain any information regarding patient grievances.
On the morning of 09/26/13, a different policy was provided to the surveyors. The policy was titled, "Patient Grievance Policy." The policy did not clearly define a grievance and did not clearly differentiate between what constituted a grievance versus a complaint.
Patient's Rights information given to patients did not include information on the hospital's grievance process, including the requirement of written responses to grievances and time frames for the responses.
A hospital policy, titled, "Patient's Bill of Rights" did not document information that the patient/representative could direct a complaint or grievance to the Oklahoma State Department of Health. The policy documented, "... The patient has the right to file a grievance with CEO at any time ..."
On the afternoon of 09/25/13, staff K was asked if she knew how a patient could file a grievance. She stated that she "really did not know, but would say 'take it up with administration'."
On 09/26/13 at 10:55 a.m., staff M was asked what constituted a grievance. She stated, "If a patient felt treated wrong." She was asked about the hospital's grievance process. She stated, "The hospital doesn't really have a process."
Staff M was asked how the hospital notified the patient/representative about any investigation of a grievance. She stated she would call them on the telephone.
Staff M was asked if the hospital had a form they used for grievances. She stated the staff filled out the form titled, "Situation Report."
On 09/26/13 at 11:30 a.m., the Compliance Officer was asked if she responded to patients in writing concerning their grievances. She stated she did not respond to the patients in writing.
The Compliance Officer was asked if she had any other documentation that showed the grievance investigation process. She stated the incident and grievance log was the process

Based on review of hospital policy and procedure, review of governing body meeting minutes and staff interview, it was determined the hospital failed to correctly identify grievances, and failed to ensure all grievances were reviewed by the governing body or a committee appointed by the governing body.
Findings:
1. A hospital policy, titled, "Patient Grievance Policy" documented, "...The QA coordinator, with the assistance of other members of the QA committee, will review grievance management forms on at least a quarterly basis to determine any trends in the grievances and how they are being resolved...Reports of the QA committee with regard to these issues will be reported to administration on at least a quarterly basis and to the Pushmataha County Hospital board on at least an annual basis."
2. There was no documentation grievances were reviewed through the governing body or a committee appointed by the governing body. There was no evidence the facility used grievances to improve patient care.
3. A hospital binder, titled, "Incidents and Grievances 2013" was reviewed by the surveyors. There was no evidence of any governing body review.
4. On 09/26/13 at 11:30 a.m., the compliance officer was asked if she could provide further documentation on investigation of grievances. She stated she didn't have anything else and that the log book was the investigation.

Based on document review and policy and procedure review, it was determined the hospital failed to notify patients/patients' representatives of the right to file a concern with the Quality Improvement Organization (QIO), the Oklahoma Foundation for Medical Quality, for concerns regarding care or early discharge.

Findings:

A patient handout given to patients at the time of admission, titled, "Pushmataha Hospital and Home Health Patient Rights" did not provide information regarding the Medicare beneficiary's right to a QIO review for concerns regarding the quality of care provided or premature discharge.

There were no hospital policies and procedures that addressed this requirement.

Based on policy and procedure review, patient rights handouts and staff interview, it was determined the hospital failed to establish a procedure for the submission of a patient's grievance.
Findings:
A policy titled, "Patient Grievance Policy," was reviewed by the surveyors. The policy did not clearly explain how a patient could submit a written or verbal grievance.
A patient handout that is given to the patient upon admission, titled, "Pushmataha Hospital and Home Health Patient Rights," was reviewed. The patient handout does not provide the patient with information on how to submit a written or verbal grievance.
On 09/26/2013 at 1055, staff M was asked about the grievance procedure. She stated the hospital "didn't really have one."

Based on document review, hospital policy and procedure review, and staff interview, the hospital failed to provide the patient with the established time frames to review and respond to patient grievances.

Findings:

A hospital policy, titled, "Patient Grievance," documented, "The hospital employee(s) best qualified to resolve the grievance according to the written report will do so as soon as possible, but in no instance more than 10 business days after the written report is prepared..."

The "Pushmataha Hospital and Home Health Patient Rights" handout provided to patients upon admission did not include time frames to respond to grievances.

The "Pushmataha Hospital Conditions on Admission Agreement" handout provided to patients upon admission did not include time frames to respond to grievances.
The Compliance Officer was asked if she had any documentation of response to grievances. She stated she did not. She stated she did not respond to grievances in writing.

Based on policy and procedure review, hospital document review and staff interview, it was determined the hospital failed to provide the complainant with written notice of:
a. the hospital's decision on a grievance;
b. the steps taken to investigate the grievance; and
c. failed to provide a written notice of the results of the grievance process, and the date of completion.

Findings:
A hospital policy, titled, "Patient Grievance" documented, "... the individual who initiated the grievance process will be informed in writing of the steps taken to investigate the grievance, the results of the grievance process, the name and telephone of the hospitals' contact and the date of completion. This written notice of the grievance resolution will occur as soon as possible but at least within 30 business days after the grievance was first reported..."
On the morning of 09/25/13, the surveyors reviewed a binder titled, "Incidents and Grievances 2013" The binder contained no documentation of the hospital's written response to a grievance.
On 09/26/13 at 11:30 a.m., the compliance officer was asked if she had any other documentation to show grievances were responded to in writing. She stated that she didn' t respond to grievances in writing.
She was asked if there was documentation of investigative steps taken in response to a grievance. She stated she did not. She stated, "The log is the investigation."

Based on observation and staff interview, it was determined the hospital failed to ensure patient care was provided in a safe setting.

Findings:

1. During observations of the hospital, it was noted that a line isolation monitor indicated an electric patient bed in the endoscopy suite had an open ground.

The hospital staff replaced a plug on the bed and put it back into use without further testing for safety by the biomedical staff.

The bed again activated the line isolation monitor. The staff did not remove the bed for further testing and repair. The staff moved the bed to the recovery room.

2. The operating room (OR) manager was asked to show the surveyor the department's malignant hyperthermia (MH) crisis supplies. The surveyors were shown a box of dantrolene in a cluttered, disorganized cabinet inside one of the operating rooms. The staff were asked if there were any other supplies for the treatment of MH. They stated they had sterile water to mix the dantrolene.

The OR staff was asked if the department stocked refrigerated fluids. They stated they did not.

According to a Lippincott's Nursing Center article, titled, "A Practical Guide for Malignant Hyperthermia Management - May 2009,"

"... The following supplies should be available on the MH cart:

dantrolene 36 vials
sterile water (preservative free) for drug dilution
sodium bicarbonate
dextrose 50%
regular insulin
calcium chloride
furosemide
lidocaine
IV cannulas, assorted sizes
IV administration sets
syringes (assorted sizes, including 60 ml syringe to dilute dantrolene) and needle-less cannulas to inject the drug quickly into the IV site
central venous pressure kit
transducing pressure system for arterial and central venous pressure monitoring
blood collection tubes
arterial blood gas kit
nasogastric tubes
irrigation tray with piston syringe
indwelling urinary catheter tray
IV fluids (0.9% sodium chloride) and 0.9% sodium chloride irrigation solution (refrigerated)
bucket and plastic bags for ice..."

The hospital did not stock all the supplies needed in the OR to respond to a MH crisis.

The hospital did not have a current policy to address malignant hyperthermia and the medical staff had not approved a list of required MH supplies for the OR.

Based on policy and procedure review, employee training review and staff interview, it was determined the hospital failed to develop, implement and train staff on the mechanisms used to protect and prevent patient abuse, neglect and harassment.
Findings:
On the morning of 09/25/13, the surveyors reviewed the hospital's abuse and neglect policy. The policy did not provide necessary components for effective abuse protection such as prevention, screening, identifying, training, protection, investigation and reporting of abuse.
The policy did not contain a written procedure for investigating abuse allegations and did not contain methods to protect patients during an investigation.
On 9/26/13 at 2:30 p.m., staff V was asked what she would do to protect the patients during an abuse allegation. She stated she would remove the staff from patient care. She was asked if she had access to a policy for guidance. She stated she did not know.
Employee education records were reviewed. The records included a quiz titled, "Abuse and Neglect Quiz." The quiz documented three questions regarding the definition of abuse and the identification of types of abuse. There was no documentation the staff were trained on actions to take if they witnessed patient abuse by staff or others.

Based on policy and procedure review, staff interview and review of the Quality Assessment Performance Improvement Plan, it was determined the hospital failed to develop and implement a restraint policy consistent with CMS requirements.

Findings:

The hospital's restraint policy documented inappropriate reasons for the use of restraints. The policy documented, "... Restraints may be used if ... patient is cognitively impaired (e.g. disoriented, confused) ... They may also be used if patient is at high risk for falling ...wandering patients who are at high risk for falling ... Patients who should not ambulate due to medical reasons (fracture etc.)..."

The policy also documented, "... a trial period out of restraints may be permitted without necessitating an additional order to reapply restraints if the trial fails ..." The policy did not follow CMS guidance that requires restraints to be removed as soon as the unsafe situation is no longer present. The policy did not require staff to obtain a new restraint order prior to reinitiating restraints.

Administrative staff confirmed this was the only policy the facility had in place for the use of restraints.

The Quality Assessment Performance Improvement Plan had no documentation the use of restraints was monitored.

Based on hospital policy and procedure review, incident report review and medical record review, it was determined the hospital failed to ensure less restrictive interventions were attempted before physical restraints were used for one (#13) of one patient identified with restraints.

Findings:

A hospital policy, titled "Use of Restraints" documented,
" ... They (restraints) are only used after all other available techniques or resources have failed... examples of alternative interventions: patient education, reduced environmental stimuli, patient located near nurses desk, reorient to time, place, person and event, medication review, family/sitter at bedside, pain relief, positioning, ambulation, active listening, diversion techniques, toileting, hydration, activity, and cover tubes/drains to remove from visual field ..."

A hospital document, titled "Situation Report" located in a binder labeled, "Incidents and Grievances 2013" documented, "... [Patient #13] fell from the bed to the floor ... bedrails up x 4 ..."

The medical record for patient #13 documented on 08/22/13 at 9:29 p.m., the patient fell out of bed, the patient was examined by a physician's assistant. The nurses documented they placed the patient in bed and raised all four side rails.

The hospital's restraint policy documented, "... if side rails restrict the patient's movement and the patient cannot remove them, the side rail is a restraint ...The following will be documented in the medical record, utilizing the restraint flow sheet and nurses notes ... Less restrictive alternative measures attempted but not successful ..."

The medical record had no documentation the staff attempted to use less restrictive interventions before placing the patient in bed with all side rails up, restraining the patient.

There was no documentation the nursing staff obtained a physician's order for the use of side rails. The nursing staff did not perform patient assessment and monitoring required for a patient in restraints.

Based on medical record review and hospital policy and procedure review, it was determined the hospital failed to ensure a physician's order was obtained prior to, or immediately after, the initiation of a restraint for one (#13) of one patient reviewed for restraints.

Findings:

A hospital policy, titled "Use of Restraints" documented, "...The use of a restraint requires a physician's order ..."

The medical record for patient #13 documented the nurses placed the patient in bed with all four side rails raised. There was no documentation the physician was notified of this intervention.

There was no documentation an order for restraints was obtained from the physician.

Based on policy and procedure review, employee training review and staff interview, it was determined the hospital failed to ensure the staff were trained and had demonstrated competency in the use of restraints.
Findings:
A hospital policy, titled "Use of Restraints" documented, "... Training and education on the safe and proper use of restraints will be provided for all nursing personnel on an annual basis ... This will include, but is not limited to: types of restraints, indications for restraints, alternative measures, safe application of restraints, documentation requirements, patient and family education, monitoring of restraints, and QA requirements. Documentation of education will be place in employee's file ..."
Sixteen nursing staff records were reviewed for evidence of training and competency on the use of restraints. Training documented in the files included a five question quiz titled, "Restraints Quiz."
There was no documentation the nursing staff was trained on indications for restraints, documentation requirements, patient and family education, monitoring of restraints, QA requirements, and alternative measures.
None of the sixteen nursing staff records documented evidence of skills competency for the application of restraints. The training records did not contain the name or title of the person who provided the restraint education.
Staff M was asked what restraints were used in the facility. She stated, "We don't really use restraints anymore, but I think we still have wrist restraints."
A hospital policy, titled, "Use of Restraints" documented, "... " The type of device to be used: Posey (vest) restraint, soft limb restraints (wrist restraints) and mittens ..."
The policy did not identify the other items in the hospital that could be used as a restraint such as, geri-chairs and bed side rails.
Staff K was asked what restraints were used in the facility. She stated she didn't know what types of restraints were available. She stated, "We don't use restraints."

Based on record review and interviews with hospital staff, the hospital does not ensure that QAPI data presented in the QAPI meeting minutes is acted on to improve patient care and safety. The data collected for QAPI does not identify high-risk, high-volume, or problem-prone areas and incidence, prevalence and severity of problems in those areas. Problems identified by maintenance personnel and documented in the hospital's QA/PI program in a high risk area were not evaluated and acted upon.

Findings:

1. Humidity records provided for QA/PI committee evaluation and were not within acceptable ranges and were not evaluated and acted upon to bring them into the required percentages. This was documented in September 2013 QA/PI meeting minutes.

2. QA/PI committee meeting minutes for August 2013 documented problems with the line isolation monitor. There was no evidence that the hospital had taken action to solve the line isolation monitor issues.

3. Physical plant and safety issues observed during the survey by the life safety surveryor in high-risk areas of the hospital have not been identified by the QA/PI program. See K Tags 050, 062, 067, 072, 078, 106, 144 and 147.

Based on record review, oberservation and interviews with staff, the hospital's governing body does not ensure adequate resources are allocated for improving the hospital's performance and reducing risk to patients. Physical plant and safety issues identified during the survey have not been addressed acted on by the hospital's governing body to insure improving and sustaining the hospital's performance and insuring reduced risk and patient safety.

Findings:

1. There was no evidence from review of the past 12 months of fire drill logs that fire drills were conducted as required from January 2013 to June 28, 2013. Fire drills are required to be conducted quarterly on each shift.

2. The following pieces of equipment used in the surgical area were not operable and were not repaired or removed from service: 1. The vaccuum supply system cannot maintain normal pressure unless attended constantly and was being used during surgical procedures. 2. A bed that was used in the surgical area had an open ground and was not removed from service.

3. The automatic sprinkler system last inspected on October 3, 2011 and yellow-tagged meaning a repair was needed had not been repaired, reinspected and certified in reliable operating condition.

4. These findings were verified by hospital staff HH .

Based on observation and staff interview, the hospital failed to ensure there were adequate numbers of licensed registered nurses to provide nursing care to all patients in the emergency department (ED).

Findings:

1. During the survey (09/25/13 through 09/27/13), the CNO informed surveyors there is a problem with patients leaving without being seen due to one RN on staff during the hours of 0600-1000 and 2200 to 0600. The CNO stated that the RN can't always leave the ED patients they are taking care of to go and triage patients.

2. During the survey (09/25/13 through 09/27/13), ED nursing staff (V, X, Z, EE) informed surveyors when there is one RN in the department, the RN must leave the department to triage the patient(s), leaving ED patients unattended.

3. There is one RN to triage and take care of all ED patients from 0600 to 1000 and 2200 to 0600. This was verified by the CNO.

4. One registered nurse (RN) is scheduled in the ED from 0600 to 1800, one licensed practical nurse (LPN) is scheduled from 1000 to 2200, and one RN is scheduled from 1800 to 0600. This was verified by the Chief Nursing Officer (CNO).

Based on review of records and interviews with staff, the hospital failed to develop a system to ensure complete medical records were readily accessible. The hospital failed to develop a policy and procedure to ensure complete medical records could be obtained. This occurred in twelve (Records #2, 4, 5, 6, 8, 10, 11, 13, 15, 16, 17, and 18) of twelve medical records provided for review of patients who were admitted after presentation to the emergency department (ER).

Findings:

1. Upon arrival at the facility on the morning of 09/25/13, the surveyors informed administrative staff they would need to review medical records as part of the survey process. Administrative staff told the surveyors that the hospital had electronic medical records. Surveyors gave the facility the option of either providing computers and access so the medical records could be reviewed electronically or to print the entire medical records chosen for review. Administrative staff chose to print the medical records chosen by the surveyors for review.

2. The program for ER nursing documentation is a different system than the one used for inpatient.

3. The surveyors reviewed the twelve medical records identified in the initial statement for completeness. The patient names were obtained from the ER log. The disposition entries in the ER log indicated the patients were admitted to the inpatient unit.

4. While the twelve patient medical records contained the ER physician's documentation, they did not contain the ER nursing notes.

5. On 09/26 and 27/13, the surveyors ask medical records staff three times for additional/complete medical records. No additional documentation/records were provided.

6. When asked on 09/27/13, medical records staff stated they did not have a policy and procedure to direct staff on how to ensure complete medical records were obtained and provided when requested.

7. These findings were reviewed during the exit conference on 09/27/13. No additional data was provided.

Based on medical record review and interviews with hospital staff, the hospital does not ensure that all entries in the medical record contain the date and time when they were signed or authenticated in electronic and written form by the person responsible for the services provided. This occurred in nine (Records #2, 4, 5, 6, 8, and 13-16) of fourteen medical records reviewed.

Findings:

Medical records # 4, 6, 8, and 13-16 contained electronic discharge summaries, progress notes and histories and physicals (h and p) that did not contain the date and time when the report was authenticated by the physician or licensed practitioner.

Medical records #2, 4, 5, 6, and 8 contained written physician orders that did not contain the date or time the order was authenticated by the ordering physician or licensed practitioner.

Based on clinical record review, policy and procedure review and staff interview, it was determined the hospital failed to ensure practitioners authenticated verbal orders and that the receivers of verbal orders dated, timed and signed the verbal order.

1. The clinical records for patients #19, 20, 21 and #22 had multiple verbal orders that were not authenticated by the physician.

2. The records had documentation verbal orders were not timed, dated and signed by the person who received the order.

3. There was no documentation verbal orders were "read back" to the physician.

4. The hospital had no policy and procedure that guided staff on the correct use of verbal orders.

Based on clinical record review and staff interview, it was determined the hospital did not ensure the discharge summary contained all the required information.

Findings:

1. The discharge summary for patient #21 did not document where the patient was to go at the time of discharge, i.e., home, nursing facility, etc. There was no documentation of follow-up care needed.

2. The discharge summary for patient #22 had no documented final diagnosis, no disposition and no follow-up care required.

3. The clinical record for patient #19 had no documentation of a discharge summary.

Medical records staff stated the surveyors were provided with complete records.

Based on review of personnel files and staff interview the hospital failed to provide a full-time qualified dietary manager.

Findings:

Review of a correspondence in Staff I's personnel file, from The Association of Nutrition and Food Service Professional, documented, "...Before you can receive your certification and credentials, you must pay the appropriate fees ..." Until the fees are paid the credentials cannot be used. Staff I stated she has not paid the required fees.

The hospital could not provide evidence that the person identified as the hospital's dietary manager had certification as a certified dietary manager (CDM) as required by State and Federal regulation standards.

On 9/26/13 in the afternoon Staff I stated she was the dietary manager, Staff I was asked for her CDM certificate. None was provided.

Based on review of hospital documents and interviews, the hospital failed to ensure a qualified dietitian supervises the nutritional aspects of patient care.

Findings:

On 9/25/13 in the afternoon Staff C stated dietician services are provided by a contract with Staff Q.

The hospital could not provide evidence of licensure, training, competency and evaluation for the person designated as the consultant dietitian.

Based on review of hospital documents, meeting minutes, and interviews the facility did not have a current therapeutic diet manual that was reviewed and approved by the governing body, dietitian, and medical staff. The manual at the hospital provided was dated 2006. The manual is updated every five years. The most current manual is dated 2012.

Findings:
On 9/26/13, the surveyors requested the hospital's therapeutic diet manual. A manual in a green binder was provided by Staff I.

Staff I stated that the manual provided was the hospital's current manual.

Based on observation, record review and staff interview, it was determined the hospital failed to:

a. maintain the condition of the hospital for the safety and well-being of patients. See Tag A-0701;

b. inspect the emergency generator weekly and failed to ensure the emergency generator was tested monthly as required. See Tag A-0702;

c. ensure the life safety from fire requirements were met. See Life Safety Code survey;

d. ensure fire drills were conducted and failed to ensure sprinkler systems were maintained in reliable operating condition and inspected and tested periodically. See Life Safety Code survey;

e. provide for storage of trash and biohazardous waste in the operating room. See Tag A-0713;

f. maintain the functionality of areas within the operating room and in the emergency department in a manner consistent with the original design. See Tag A-0722;

g. ensure patient examinations and treatment were performed in rooms designed for that purpose. See Tag A-0723;

h. store supplies and equipment in a manner to ensure protection from contamination and failed to ensure equipment was regularly inspected, tested and maintained according to manufacturer's recommendations. See Tag A-0724; and

i. failed to ensure appropriate ventilation and air exchanges and appropriate temperature and humidity levels were maintained in the various areas of the surgery department. See Tag A-0726.

A hospital document, dated 07/08/13, indicated many of the physical environment issues were identified at that time. At the time of the survey, no corrective actions had been taken.

Based on observation, record review and staff interview, it was determined the hospital failed to maintain the condition of the hospital for the safety and well-being of patients.

Findings:

On 09/25/13, 09/26/13, and 09/27/13 the following observations were made of the hospital:

1. Surgery Department

~Exhaust fans in critical areas such as sterile processing, endoscope processing and soiled work areas were broken or not installed.

~The hospital could not test and verify proper air exchanges in the operating room.

~Proper humidity levels were not maintained in the operating room. There was documentation a humidifier was removed and never replaced by the hospital.

~A vacuum supply system for the operating room was not functioning properly and had not been repaired.

~Loaner equipment used for dental surgery was not inspected and tested for safety before use on patients.

~Ceilings, walls, and floors in the operating room were damaged and in need of extensive repair. The surfaces were not intact, exposed particle board or other porous surfaces were found. Bare plywood was used in the operating room. Metal surfaces were rusted. Ceiling tiles throughout the surgery department were damaged by water and mold, were cracked, had holes, or were missing completely.

~Cabinetry was in disrepair and doors/drawers could not remain closed.

2. There were areas in the hospital that showed evidence of roof leaks. Internal damage to ceilings and walls had not been repaired.

3. The hospital did not have a routine and preventive maintenance schedule for equipment throughout the hospital.

When maintenance and nursing staff were asked about the condition of the hospital, they stated, "A lot of work needs to be done."

Based on observation, document review and staff interview, it was determined the hospital failed to inspect the emergency generator weekly and failed to ensure the emergency generator was tested monthly as required.

Findings:

1. On 09/26/13, the hospital was asked to provide records of emergency generator inspection and testing. There was no documentation of weekly testing. The documentation provided did not document if the generator was run under load and for how long.

2. There was no documentation of the percentage of load the generator was tested.

3. There was no documentation of the length of time the generator was run.

4. Maintenance personnel could not provide documentation of when the diesel fuel was last treated.

See Life Safety Code survey.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure the life safety fire requirements were met.

See Life Safety Code survey Statement of Deficiencies.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure:

a. fire drills were conducted at unexpected times, under varying conditions and at least quarterly on each shift. See Tag K-050 Life Safety Code survey; and

b. failed to ensure sprinkler systems were maintained in reliable operating condition and inspected and tested periodically. See Tag K-062 Life Safety Code survey.

Based on observation and staff interview, it was determined the hospital failed to provide for storage of trash and biohazardous waste in the operating room.

On 09/25/13, a tour was conducted of the operating room. Trash and biohazardous waste was stored in a hallway leading into the operating room (OR).

OR staff verified the surgery department did not have a room inside for storage of trash and biohazardous waste.

Based on observation, document review and staff interview, it was determined the hospital failed to maintain the functionality of areas within the operating room and in the emergency department in a manner consistent with the original design.

Findings:

On 09/25/13, the following observations were made of the surgery department and the emergency department.

Surgery

~The surgical instrument decontamination room had been changed into an employee break room. The area now used to decontaminate instruments did not conform to the design requirements for this type of room and did not allow for the proper work flow from contaminated to clean/sterile then to storage. There was no separate staff handwashing sink.

~A handwashing sink was provided within the sterile processing area, but it could not be used by staff because no soap and paper towel dispensers were installed.

~A blanket warmer was installed in the sterile processing room in a wall next to the steam sterilizer. This allowed for unnecessary traffic in and out of the restricted sterile processing area.

~The recovery room, housed within the surgery department sterile core, was also used as an outpatient examination room. Minor procedures were done in this room when the surgery department was not open. It was confirmed by staff that outpatients, visitors and physicians entered the sterile core of the surgery department in street clothes to use the recovery room for examination and treatment.

~Staff scrub attire was stored within the sterile core rather than in the dressing areas. Staff had to enter the sterile corridor in street clothes to access scrub attire.

~The sterile corridor outside the operating rooms was used as office space. The area contained office machines, books, binders, papers and supplies and equipment used in an office.

~A plastic tub containing Cidex was stored in the sterile corridor, rather than in a decontamination area with proper ventilation.

~Endoscope processing was done in a soiled utility room that was not designed for this purpose. The room did not allow for proper negative/positive airflow and did not conform to requirements to separate dirty from clean processes. The room did not provide for a separate staff handwashing sink.

~A janitor's closet was used to store surgical equipment.

~The corridor into the surgery department was used to store biohazardous waste and regular trash.

Emergency Department

~A consultation room was being used as a triage room.

~The original triage room was being used as an employee break room.

~A tub room was being used for storage of medical supplies and equipment and used to house the fluid and blanket warmer.

~A soiled utility room was used for both dirty and clean supplies and equipment.

~An examination room was used to store equipment (both functioning and non-functioning) such as gurneys, wheelchairs and portable oxygen tanks.

Based on observation and staff interview, it was determined the hospital failed to ensure patient examinations and treatment were performed in rooms designed for that purpose.

Findings:

1. The recovery room, housed within the surgery department sterile core, was also used as an outpatient examination room. Minor procedures were done in this room when the surgery department was not open. It was confirmed by staff that outpatients, visitors and physicians entered the sterile core of the surgery department in street clothes to use the recovery room for examination and treatment. The staff stated the recovery room was used for post-operative doctor visits.

2. In the emergency department, a carpeted consultation room was being used for triage. The original triage room was used as an employee break room.

3. A review of the hospital's blueprints and interviews with staff verified that patient treatment was done in areas not designed for that purpose.

Based on observation, record review and staff interview, it was determined the hospital failed to store supplies and equipment in a manner to ensure protection from contamination and failed to ensure equipment was regularly inspected, tested and maintained according to manufacturer's recommendations.

Findings:

On 09/25/13, 09/26/13 and 09/27/13, observations were made of the following:

Emergency Department

1. A tub room was used to store clean and sterile medical supplies. A fluid and blanket warmer was found in this room. Biohazardous waste was found stored in this area.

2. A soiled work room was used also as a clean work room.

3. Broken equipment was stored with functioning equipment in an exam room.

4. Gurney pads were torn and had been repaired with tape.

5. Portable oxygen tanks were stored unsecured.

6. Cleaners and disinfectants were stored with internal and external medications and sterile solutions.

7. Sterile supplies in peel packs were stored in a manner to compromise the integrity of the package.

8. Unpacked corrugated shipping boxes were found in all storage areas.

9. Sterile and non-sterile supplies were stored together.

10. Open bottles of sterile irrigating solutions were found on counters and in cabinets.

Surgery

1. Clean surgical equipment was stored in the janitor's closet.

2. Unpacked corrugated shipping boxes were found in several areas within the surgery department, including the sterile processing area and endoscope processing area.

3. Clean and dirty items were stored together.

4. Sterile and non-sterile supplies were stored together. Sterile supplies were stored in a manner to compromise the integrity of the packaging. Surgical instruments too heavy or too bulky were processed for sterilization in peel packs.

5. Rusted metals racks and cabinets were used to store surgical supplies.

6. A mechanical room for the steam sterilizer was used to store surgical supplies. The room had evidence of a ceiling water leak. Walls were water-stained and had evidence of black mold. Sheet rock was peeling. Ceiling tiles were missing allowing open access to the attic. The surgical supplies stored here were also exposed to excessive heat and humidity from the steam sterilizer.

7. Operating room (OR) table parts were stored with mop buckets.

8. Supplies were stored on the floor of the endoscope decontamination room.

9. The emergency cart in the OR was not adequately secured to prevent loss or tampering. Non-emergency supplies and unrelated equipment were stored with emergency supplies and equipment in this cart.

10. Open bottles of sterile irrigating solutions were found on counters and in cabinets.

Hospital-wide

1. The hospital's Medical Equipment Management Plan approved in February 2013, documented life sustaining equipment would have testing and preventive maintenance semi-annually.

Maintenance staff did not provide a hospital-wide repair and maintenance program for all medical equipment. No maintenance logs were provided.

Numerous pieces of medical equipment, including life sustaining equipment in the emergency department and in surgery, did not have regular inspection and testing.

The surgery department anesthesia machine was last tested on 10/17/12. The manufacturer recommended testing at least every six months.

Portable radiology equipment was last checked in 2003.

Some equipment found in the emergency department and in surgery had no documentation of any inspection and testing. Loaner equipment in surgery had not been included in the biomedical maintenance program and had never been inspected for safety and proper functioning.

Staff were asked, but did not produce evidence the steam sterilizer had regular testing, service or repairs. The staff stated this equipment regularly failed.

2. A hospital bed that activated the line isolation monitor showing it had an "open" ground. After a new electrical plug was installed on the bed, it was not tested. The bed again set off the line isolation monitor. Rather than taking it out of service, the bed was moved to the recovery area to be used by patients.

Based on observation, record review and staff interview, it was determined the hospital failed to ensure appropriate ventilation and air exchanges and appropriate temperature and humidity levels were maintained in the various areas of the surgery department.

Findings:

1. The hospital could not provide evidence that negative airflow was maintained in the decontamination areas.

2. The hospital could not provide evidence required air exchanges per hour were maintained. There was no evidence proper air exchanges were provided where guteraldehyde was used.

3. There was no documentation positive airflow was maintained in the clean and sterile areas of the department.

4. The staff provided a temperature/humidity log for the surgery department that indicated chronic high and low levels of humidity at various times of the year. There was documentation the maintenance department was notified of the problem. There was no record of corrective actions taken. The maintenance staff stated the surgery department humidifier had been removed but never re-installed.

Based on observation, interviews with staff and review of hospital documentation, the hospital failed to maintain an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff.

Findings:

1. The staff identified as the infection control preventionists did not have training in establishing and maintaining an effective ongoing infection control program. (Refer to Tag A - 0748)

2. The infection control practitioner has not ensured that infection control policies and procedures have been developed for each unit/area of the hospital. (Refer to Tag A- 0748)

The disinfectants used throughout the hospital have not been reviewed and approved by the hospital's Infection Control committee through the quality program. (Refer to Tag A- 0749)

3. The hospital does not have an ongoing infection control program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained. (Refer to Tag A-0749).

4. Leadership does not ensure infection control concerns and issues are reviewed, analyzed and corrective actions are taken through the quality assessment and performance improvement process. (Refer to Tag A-756).

5. Surgery department cleaning and disinfection:

~On 09/25/13, observations were made of the operating room. The OR table had clean linen on it. The staff stated the room had been terminally cleaned by the housekeeping staff. However, suture was found on the floor from a previous case. A plastic cap from a syringe was found under the anesthesia machine. There was contaminated trash from a previous case on the anesthesia cart.

~The operating room ceilings, walls, floors and surfaces were not intact and could not be disinfected. Bare plywood, particle board and rusted metal surfaces were found in the operating room.

~Foam padding on some equipment was torn and taped back together. Some padding had exposed foam that could not be disinfected between uses.

~There was no evidence the entire surgery department was terminally cleaned on a regular basis. There was no evidence of periodic deep cleaning and floor maintenance.

~Office equipment and supplies and clutter were found stored out in the sterile corridor, in the decontamination rooms and in the sterile processing room. Because these items were not stored in protected drawers or shelves, they prevented adequate terminal cleaning of the area. These items could not be cleaned according to surgery department requirements.

~An upholstered modular desk/cabinet was found in an operating room. This piece could not be adequately disinfected as required.

~Various types of disinfectant products were found in the surgery department. Staff could not say definitively what product should be used when and where. There were no departmental policies for the correct use of the disinfectants.

~The recovery room within the surgery department was cluttered and had the appearance it was not terminally cleaned. Many surfaces were so damaged they could not be sanitized.

~The staff person identified as the housekeeper for the surgery department had no documentation of prior experience as a housekeeper or specialized training to provide this service in an operating room. There was no documentation this person was oriented to the department, trained and verified as competent to perform the special cleaning and disinfection processes required for the operating room.

6. Sterilization practices

~The hospital had inadequate records of surgical instrument sterilization. The only steam sterilization records provided were for 08/05/13 to the present. The staff stated they did not have records before this time.

For the loads with documentation, each sterilization cycle did not have all required information, such as:

lot number
specific contents of the load including quantity, department and description
exposure time and temperature
the name of the operator

There was no documentation of failed cycles and corrective actions.

~OR staff stated dental surgeries were performed at the hospital. They stated the dentists brought their own sterile dental instruments to the hospital. The staff were asked if they had verified the disinfection and sterilization processes were adequate at the dentists' offices. They stated they had not.

~The hospital did not provide for immediate use sterilization. The staff stated the autoclave did not have "flash" capability. When asked what they did when an instrument needed immediate sterilization, they stated they used a Cidex OPA soak. The staff did not understand Cidex OPA is a high level disinfectant and does not provide sterilization. The staff had no records of items placed in the Cidex OPA.

~The sterile processing room was not adequately equipped and maintained. There were no racks to cool hot instruments to prevent condensation and contamination. The area was not cleaned appropriately. Corrugated shipping boxes were found in the room.

~Peel packages containing surgical instruments were written on with permanent marker. Peel packages were used to sterilize large and bulky items that were not appropriate for peel packages. Peel packages were stored crushed, bent and compressed in a way to damage the integrity of the packaging.

~The hospital did not have policies to address sterilization practices and the storage of sterile supplies.

~There was no documentation of orientation, training and skill competency evaluation for those staff who performed sterilization of surgical instruments and supplies. The files documented only a self-assessment.

7. Endoscope processing

~The staff did not have adequate records of endoscope processing. Records were requested for the entire year. The records provided were for 07/23/13 to the present. The Cidex OPA solution testing was only documented with "pass/fail." There was no documentation the solution was tested before the first load of the day. The test strips were not dated when they were opened and did not document an expiration date.

~Large bottles of Cidex OPA were not dated when opened and did not have a documented expiration date.

~Every scope processed was documented with a soak time of 12 minutes. The manufacturer's instructions documented, "... minimum of 12 minutes at 68 degrees F or higher to destroy all pathogenic organisms..."

~There was no documentation the temperature of the solution was monitored and maintained above 68 degrees as required by the manufacturer.

~Surgical endoscopes were processed in an area too small and inadequately designed for the task. This allowed for cross-contamination during the decontamination process.

~There was not adequate sink space and separation of the "dirty" sink from the "clean" sink. The clean sink was not large enough to hold an endoscope and adequately flush and rinse it. There was no separate dirty and clean counter space. The room did not have adequate negative pressure and air exchanges.

~The endoscope decontamination room was not terminally cleaned.

~The hospital had no current policies for endoscope processing. There were no current policies for the use of Cidex OPA.

~The hospital did not have a process in place to monitor and re-disinfect endoscopes that had been in storage for more than five days.

~The hospital did not record the scope number used on patients neither in the surgery department nor in the patients' clinical record. Three (#20, 21 and #22) of three records reviewed for patients who had endoscopic procedures did not have documentation of the scope number used on their case.

8. Equipment and supply storage

~Sterile supplies were not stored correctly. Sterile supplies were stored with non-sterile supplies. Sterile supplies were stored with cleaning products.

~Surgical equipment was stored in a janitor's closet and supplies were stored in a mechanical room.

~Clean and dirty items were stored together.

~Surgical supplies and equipment were exposed to excessive heat and humidity. They were exposed to rust from metal shelving and cabinetry. Supplies were exposed to dust from open or missing ceiling tiles. Supplies were stored near the floor, on the floor, touching outside walls and less than two inches from the ceiling. Items stored on lower shelves were not protected from housekeeping activities.

9. Handwashing

~Separate staff handwashing sinks were not available in the instrument decontamination room and the endoscope processing room.

~A handwashing sink was available in the sterile processing room but soap and paper towels were not provided.

10. Laundry

~Staff stated cloth surgical gowns were used by physicians who performed endoscopy procedures. The staff stated the hospital provided it's own laundry service and processed these gowns.

~A household plastic laundry basket was observed on the floor outside the operating room where endoscopies were performed. The staff stated the physician discarded the cloth gowns in this basket when the case was completed. The basket was not lined with a plastic bag. The staff stated they carried the basket to the laundry room (in another building) and deposited the soiled gowns there. They stated they brought the basket back to the operating room.

~The surgery department had no policies for handling soiled linens.

~The hospital laundry room was observed. The side with the washer and dryer had dirty and clean items in it. This room also had a large utility sink and a hopper. There was no designation between clean and dirty areas in this room.

~The laundry staff stated they had no way to monitor water temperatures or levels of sanitizer. They were not aware of cycle times.

~The laundry staff had no policies and procedures for the provision of laundry services.

Based on review of personnel files and meeting minutes, and interviews with hospital staff, the hospital failed to ensure:

a. The staff identified as the infection control preventionist/practitioner (ICP) has training in establishing and maintaining an effective ongoing infection control program based on current principals and methods of infection control;

b. The ICP has developed infection control policies and procedures for each department/area of the hospital according to current standards of practice.

Findings:

1. On 09/25/13, administrative staff identified Staff Y as the person responsible for infection control with Staff GG as the Director of Infection Control. Governing Body meeting minutes for July 2013 documented appointment of Staff Y as the ICP and Staff GG as the Infection Control Officer.

a. Review of Staff Y's personnel file did not demonstrate Staff Y had any training or experience in establishing and maintaining an effective and ongoing infection control program. This was confirmed with Staff Y on 09/25/13 at 1345.

b. Staff GG did not have a personnel file at the hospital. The personnel file that was submitted for review was from another hospital. Review of Staff GG's personnel file from this other hospital did not demonstrate Staff GG had ongoing training in establishing and maintaining an effective and ongoing infection control program. This was confirmed with Staff GG on 09/26/13.

2. The infection control policy and procedure for bloodborne pathogen exposure did not specify how records of exposures would be maintained, except they would be confidential. Staff Y stated they were identified by name and she kept them in the employee's health file.

3. Staff A told the surveyors the hospital did its only laundry services for gowns and sheets. The hospital did not have policies and procedures concerning laundry procedures.

Based on observation, review of infection control data, surveillance activities, personal files, meeting minutes, and hospital documents, and interviews with hospital staff, the hospital failed to ensure the infection control practitioner (ICP) developed and maintained an ongoing comprehensive system for reporting, analyzing and controlling infections and communicable diseases among patients and staff and ensuring a sanitary environment.

The hospital does not have an ongoing infection control/prevention (IC) program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained.

Findings:

Program:

1. The program's current plan documented immediate use sterilization would be followed. The program failed to identify that no immediate use/flash sterilization was being performed, because the hospital's sterilizers did not have this function. Equipment/instruments needed for emergency use were being returned for use after only a high level disinfection.

2. Staff A told the surveyors on 09/26/13 at 1115 that housekeeping staff did the laundry of gowns and sheets used in the hospital. The program failed to identify this area of service; develop policies and procedures; and monitor these services to ensure the service was performed according to regulatory requirements and current standards of practice.

3. The program does not monitor employee health.
a. Staff illness were not compared to patient infections to ensure communicable diseases and infections are not transmitted between staff and patients.

b. Staff immunizations are not complete as required by State Licensure Hospital Standards and recommended by Centers for Disease Control (CDC) and it's advisory committee (ACIP). Findings include, but not limited to:
i. Three of three physician files reviewed did not demonstrate complete immunizations histories.
ii. A laboratory report for staff KK indicated no immunity to varicella and rubeola. There was no documentation of any actions taken by the hospital as a result of this finding.
iii. Staff DD did not have current TB skin testing.
iv. The hospital did not obtain immunization records for dental assistants that provided patient care in the OR.


Observation:

1. Surgery department cleaning and disinfection:

~On 09/25/13, observations were made of the operating room. The OR table had clean linen on it. The staff stated the room had been terminally cleaned by the housekeeping staff. However, suture was found on the floor from a previous case. A plastic cap from a syringe was found under the anesthesia machine. There was contaminated trash from a previous case on the anesthesia cart.

~The operating room ceilings, walls, floors and surfaces were not intact and could not be disinfected. Bare plywood, particle board and rusted metal surfaces were found in the operating room.

~Foam padding on some equipment was torn and taped back together. Some padding had exposed foam that could not be disinfected between uses.

~There was no evidence the entire surgery department was terminally cleaned on a regular basis. There was no evidence of periodic deep cleaning and floor maintenance.

~Office equipment and supplies and clutter were found stored out in the sterile corridor, in the decontamination rooms and in the sterile processing room. Because these items were not stored in protected drawers or shelves, they prevented adequate terminal cleaning of the area. These items could not be cleaned according to surgery department requirements.

~An upholstered modular desk/cabinet was found in an operating room. This piece could not be adequately disinfected as required.

~Various types of disinfectant products were found in the surgery department. Staff could not say definitively what product should be used when and where. There were no departmental policies for the correct use of the disinfectants.

~The recovery room within the surgery department was cluttered and had the appearance it was not terminally cleaned. Many surfaces were so damaged they could not be sanitized.

~The staff person identified as the housekeeper for the surgery department had no documentation of prior experience as a housekeeper or specialized training to provide this service in an operating room. There was no documentation this person was oriented to the department, trained and verified as competent to perform the special cleaning and disinfection processes required for the operating room.

2. Sterilization practices:

~The hospital had inadequate records of surgical instrument sterilization. The only steam sterilization records provided were for 08/05/13 to the present. The staff stated they did not have records before this time.

For the loads with documentation, each sterilization cycle did not have all required information, such as:

lot number
specific contents of the load including quantity, department and description
exposure time and temperature
the name of the operator

There was no documentation of failed cycles and corrective actions.

~OR staff stated dental surgeries were performed at the hospital. They stated the dentists brought their own sterile dental instruments to the hospital. The staff were asked if they had verified the disinfection and sterilization processes were adequate at the dentists' offices. They stated they had not.

~The hospital did not provide for immediate use sterilization. The staff stated the autoclave did not have "flash" capability. When asked what they did when an instrument needed immediate sterilization, they stated they used a Cidex OPA soak. The staff did not understand Cidex OPA is a high level disinfectant and does not provide sterilization. The staff had no records of items placed in the Cidex OPA.

~The sterile processing room was not adequately equipped and maintained. There were no racks to cool hot instruments to prevent condensation and contamination. The area was not cleaned appropriately. Corrugated shipping boxes were found in the room.

~Peel packages containing surgical instruments were written on with permanent marker. Peel packages were used to sterilize large and bulky items that were not appropriate for peel packages. Peel packages were stored crushed, bent and compressed in a way to damage the integrity of the packaging.

~The hospital did not have policies to address sterilization practices and the storage of sterile supplies.

~There was no documentation of orientation, training and skill competency evaluation for those staff who performed sterilization of surgical instruments and supplies. The files documented only a self-assessment.

3. Endoscope processing:

~The staff did not have adequate records of endoscope processing. Records were requested for the entire year. The records provided were for 07/23/13 to the present. The Cidex OPA solution testing was only documented with "pass/fail." There was no documentation the solution was tested before the first load of the day. The test strips were not dated when they were opened and did not document an expiration date.

~Large bottles of Cidex OPA were not dated when opened and did not have a documented expiration date.

~Every scope processed was documented with a soak time of 12 minutes. The manufacturer's instructions documented, "... minimum of 12 minutes at 68 degrees F or higher to destroy all pathogenic organisms..."

~There was no documentation the temperature of the solution was monitored and maintained above 68 degrees as required by the manufacturer.

~Surgical endoscopes were processed in an area too small and inadequately designed for the task. This allowed for cross-contamination during the decontamination process.

~There was not adequate sink space and separation of the "dirty" sink from the "clean" sink. The clean sink was not large enough to hold an endoscope and adequately flush and rinse it. There was no separate dirty and clean counter space. The room did not have adequate negative pressure and air exchanges.

~The endoscope decontamination room was not terminally cleaned.

~The hospital had no current policies for endoscope processing. There were no current policies for the use of Cidex OPA.

~The hospital did not have a process in place to monitor and re-disinfect endoscopes that had been in storage for more than five days.

~The hospital did not record the scope number used on patients neither in the surgery department nor in the patients' clinical record. Three (#20, 21 and #22) of three records reviewed for patients who had endoscopic procedures did not have documentation of the scope number used on their case.

4. Equipment and supply storage:

~Sterile supplies were not stored correctly. Sterile supplies were stored with non-sterile supplies. Sterile supplies were stored with cleaning products.

~Surgical equipment was stored in a janitor's closet and supplies were stored in a mechanical room.

~Clean and dirty items were stored together.

~Surgical supplies and equipment were exposed to excessive heat and humidity. They were exposed to rust from metal shelving and cabinetry. Supplies were exposed to dust from open or missing ceiling tiles. Supplies were stored near the floor, on the floor, touching outside walls and less than two inches from the ceiling. Items stored on lower shelves were not protected from housekeeping activities.

5. Handwashing:

~Separate staff handwashing sinks were not available in the instrument decontamination room and the endoscope processing room.

~A handwashing sink was available in the sterile processing room but soap and paper towels were not provided.

6. Laundry:

~Staff stated cloth surgical gowns were used by physicians who performed endoscopy procedures. The staff stated the hospital provided it's own laundry service and processed these gowns.

~A household plastic laundry basket was observed on the floor outside the operating room where endoscopies were performed. The staff stated the physician discarded the cloth gowns in this basket when the case was completed. The basket was not lined with a plastic bag. The staff stated they carried the basket to the laundry room (in another building) and deposited the soiled gowns there. They stated they brought the basket back to the operating room.

~The surgery department had no policies for handling soiled linens.

~The hospital laundry room was observed. The side with the washer and dryer had dirty and clean items in it. This room also had a large utility sink and a hopper. There was no designation between clean and dirty areas in this room.

~The laundry staff stated they had no way to monitor water temperatures or levels of sanitizer. They were not aware of cycle times.

~The laundry staff had no policies and procedures for the provision of laundry services.

7. Inpatient Unit:
~The crash cart was dirty and not maintained for cleanliness.

~Staff had not been inserviced on disinfectant application.


Meeting minutes:
1. Meeting minutes for infection control contained the same plan of action - "ongoing". Reports of infections were provided, but no review of analysis was documented. There was no corrective actions to improve patient safety and ensure a sanitary environment. Deficient practices identified by the surveyors were not identified by infection prevention surveillance or included in meeting minutes.

2. Meeting minutes did not demonstrate deficient practices identified during surveillance were reviewed at infection control committee meetings with corrective actions developed.

3. Meeting minutes reviewed since February 27, 2013 did not demonstrate a physician attended the infection control committee meeting.

Based on review of hospital documents and meeting minutes concerning infection control, and infection control policies and procedures, and interviews with hospital staff, the hospital's leadership failed to ensure infection control activities, issues, and problems, were processed through quality assessment and performance improvement (QAPI) committee and:

1. Were monitored throughout the hospital, reviewed and analyzed;

2. Corrective actions were taken to prevent, identify and manage infections and communicable diseases with measures that resulted in improvement on an ongoing basis; and

3. Corrective actions were followed to ensure improvement resulted and alternative solutions/actions were not needed.

Findings:

1. Hospital meeting minutes for 2013 were reviewed. The meeting minutes provided to the surveyors during the on-site survey containing infection control data, QAPI, medical staff, governing body, and Infection Control Committee, did not contain evidence/demonstrate the hospital leadership:
a. Reviewed and analyzed infection control data or lack thereof;
b. Ensured that all departments/units of the hospital were included and monitored through the infection control/prevention program;
c. Ensured infection control/prevention policies and procedures were developed, implemented and followed to ensure a safe and sanitary environment and that staff were inserviced on those policies;
d. Developed corrective plans of action to reduce and/or prevent transmission of organisms and improve patient care, ensure a safe and sanitary environment, and prevent or decrease infections and communicable diseases; and
e. Provide follow-up/monitoring to ensure corrective actions taken were effective and sustainable.

2. The same hospital minutes did not contain analysis of employee immunizations, illness and infections to ensure infections and diseases were not transmitted between patients and staff.

3. Meeting minutes did not contain evidence the hospital's leadership has ensured policies and procedure were developed for all areas of the hospital concerning current accepted standards of practice in infection control. The hospital provided on-site laundry services. No policies had been developed to assure the service was performed according to regulatory requirements and current standards of practice.

4. The hospital offers surgical services, including endoscopy procedures. The meeting minutes did not demonstrate the leadership of the hospital ensured surgical services were provided in a safe and sanitary environment according to current standards of practice (Refer to Tags A 749 for details). The infection control portion of the meeting minutes did not demonstrate issues observed by the surveyors were identified, analyzed and corrective actions taken with follow-up to ensure compliance.

5. The hospital's leadership did not ensure that corrective actions were implemented for concerns identified through infection control surveillance. For example:

a. The agenda for the March 2013 Infection Control Committee listed approval of disinfectants. Meeting minutes did not reflect this occurred. The topic was not repeated in any other meeting minutes.

b. The June 12, 2013 Infection Control Committee meeting minutes documented problems with the respirator fit testing of three employees. Corrective action was identified as borrowing another type of respiratory mask from another hospital. The "Follow-Up" section recorded the action was to be followed at the next meeting. This was not done.

c. July 2013 "OR (operating room) Observation Checklist" identified problems that were not addressed, or corrective actions taken, in either the July or August 2013 meeting minutes. No September 2013 meeting minutes were provided for review. The problems identified included, but not limited to:
i. Bare paper in the OR core,
ii. Porous ceiling tile in the OR,
iii. Issues with traffic flow. Clean and dirty travel through same area,
iv. Unfinished pegboard on walls in recovery and endoscopy
v. Sharps were not passed in a basin or by using neutral zone rather than by hand.

Based on document review and staff interview, it was determined the hospital failed to provide a discharge planning process.

Findings:

1. On 09/26/13, the hospital was asked to provide it's discharge planning policies and procedures.

Two policies were provided; one titled, "Discharge Planner" and another titled, "Discharge Planning Committee."

The director of nursing (DON) stated the hospital did not have a discharge planner or a discharge planning committee.

2. The nursing staff stated they did some discharge planning activities as needed but they said they had no training in discharge planning and had no policies and procedures to follow.

3. The clinical record for patient #21 documented the physician ordered wound care to be done by a home health agency when the patient was discharged. There was no documentation the staff offered a list of local home health agencies for the patient's choice. There was no documentation a home health agency was contacted by the hospital and given the physician's instructions for wound care.

Based on observation, document review, medical record review and staff interview, it was determined the hospital failed to:

a. limit access to the operative and recovery area. Staff stated the recovery room, located within the surgical core, was used after hours as an examination and treatment room for outpatients. Physicians, patients and visitors walked through the surgical corridor in street clothes and entered the recovery room. Parents of children in the recovery room were allowed to enter the department without proper attire;

b. perform appropriate cleaning between surgical cases. Used suture, used parts of syringes and contaminated trash was found in an operating room identified by staff as terminally cleaned. By all appearances, the entire surgical department did not receive terminal cleaning and regular deep cleaning;

c. ensure operating room attire was covered when staff exited the surgery department. Staff were observed in surgery scrubs, uncovered, outside the department. Staff regularly left the department in surgical attire and returned without changing their scrubs. Staff who donned coverall "bunny suits" to enter the operating room wore them outside the OR and then returned to the OR without changing them. Clean scrubs were stored inside the sterile core and not in the changing rooms;

d. provide immediate use steam sterilization. The staff stated the autoclave for the surgery department could not "flash" sterilize. They stated they used Cidex to flash sterilize;

e. ensure surgical equipment was monitored, inspected, tested and maintained. Life sustaining equipment such as the anesthesia machine and the defibrillator were not monitored and tested twice a year as required by hospital policy and procedure. Some equipment had no documentation of any inspection, testing and maintenance. Loaner surgical equipment was put into service without inspection and testing;

f. ensure sterilized materials were packaged, handled, labeled and stored correctly. See Tag A-0747;

g. maintain proper temperature, humidity, ventilation and air exchanges in the various areas of the surgery department. See Life Safety survey;

h. ensure surgical services were integrated into the QAPI program;

i. define the scope of surgical services in writing, failed to approve the scope of surgical services through the medical staff and failed to provide an organizational chart that indicated lines of authority and delegation of responsibility. See Tag A-0941;

j. ensure the surgery department was supervised by an experienced registered nurse. See Tag A-0942;

k. ensure trained surgical technologists (operating room technicians) served as "scrub nurses." See Tag A-0943;

l. ensure experienced registered nurses were assigned as circulating nurses. See Tag A-0944;

m. maintain a roster of practitioners with surgery privileges. See Tag A-0945;

n. develop, implement and enforce surgical policies and procedures based on current nationally recognized standards. See Tag A-0951;

o. provide all the required emergency equipment for the operating room. See Tag A-0956;

p. provide post-operative care within acceptable standards of practice. See Tag A-0957; and

q. failure to maintain an operating room register with all the required elements. See Tag A-0958.

Based on record review and staff interview, it was determined the hospital failed to define the scope of surgical services in writing, failed to approve the scope of surgical services through the medical staff and failed to provide an organizational chart that indicated lines of authority and delegation of responsibility.

Findings:

1. The hospital's policies and procedures for surgical services had no documentation to define the scope of surgical services. There was no documentation the medical staff approved the scope of surgical services.

2. The operating room staff stated they did not have a current surgery department organizational chart and could not identify a chief of surgery appointed by the medical staff.

3. Some surgery policies and procedures referenced the use of an anesthesiologist. The hospital has no anesthesiologist on staff.

4. Non-hospital staff were allowed to work in surgery without application, verification and medical staff approval as members of the allied health staff.

Based on document review, observation and staff interview, it was determined the hospital failed to ensure the surgery department was supervised by an experienced registered nurse.

Findings:

The hospital had no policy that defined the qualifications necessary for the surgery department manager.

The employment file for the registered nurse identified as the surgery department manager had no documentation the hospital verified past surgery work experience. The file had no documentation of verified surgery management/supervisory experience.

There was no documentation of professional reference checks.

The file documented the registered nurse (RN) became the surgery manager on 03/18/13. At the time of the survey, no evaluation was documented for this nurse in the position as surgery manager. The only job performance evaluation in the file was a self-evaluation for a circulator position completed on 03/18/13.

The file had no documentation of continuing education, specialized training or certification for the position. There was no documentation of membership in any surgery-related professional organization.

During a tour of the surgery department and through interview, the surgery manager was unable to answer many questions related to the processes and functions of the department.

She stated she was required to perform direct patient care from the pre-op phase, through surgery and then through recovery.

Based on record review and staff interview, it was determined the hospital failed to ensure trained surgical technologists (operating room technicians) served as "scrub nurses."

Findings:

1. At the time of the survey, the surgery manager stated dental surgery cases were performed every week. She stated the dentists came to the hospital with dental technicians who performed scrub nurse duties.

The dental technicians were not employees of the hospital. They had not been credentialed by the medical staff as allied health staff members.

A review of the operating room (OR) register documented six non-employees were "assistants" during surgical cases. The hospital had an incomplete file for one person, a dental assistant. There were no files for the others.

The application in the file had no documentation of training and experience as a scrub tech. The file had no personal or professional references.

The file had documentation of an expired certificate to perform radiology through the board of dentistry. The file contained an expired cardiopulmonary resuscitation (CPR) certificate from 2005. There was no documentation the medical staff appointed this person to the allied health staff roster.

The OR manager was asked if she knew anything about the credentials of the non-employees who performed scrub duties or assisted in the operating room. She stated she did not.

2. One hospital staff person identified as a "scrub tech" had no documentation of prior medical experience or training before coming to work at the hospital. The file documented the tech had worked as a substitute teacher, a lunch room aide, and as a waitress before coming to work at the hospital as a nurse's aide.

The file documented this staff person transferred from the medical-surgical unit to the operating room in March of 2010.

There was no documentation the tech had surgery department orientation, or received training as a scrub tech. There was no documentation that the scrub tech's skills were evaluated for competency.

A skills checklist, dated 03/27/13, documented the tech needed an "update, policy and procedure review and more theory and practice" on:

draping the surgical patient
code green procedures
knowledge of anatomy and physiology
infection control practices
body substance isolation
cold disinfection

In addition to scrub tech duties, this staff person was assigned to perform sterilization and disinfection of surgical instruments. There was no documentation of training and evaluation to verify this staff person was competent to perform these tasks.

3. The file for another certified surgical technologist (CST) had a skills checklist signed by an RN and another experienced CST. The checklist, dated 05/06/13 had numerous gaps in documentation where the following skills were not addressed:

arrange back table
timely placement of instruments on Mayo stand
drapes appropriately
emergency codes
infection control
body substance isolation
hazardous waste
latex allergy
skin prep

The file had no documentation of professional reference checks or verification of previous employment.

Based on record review and staff interview, it was determined the hospital failed to ensure experienced registered nurses were assigned as circulating nurses.

Findings:

1. On 09/26/13, the operating room (OR) manager was asked to provide a list of surgery staff. The list documented there were two registered nurses working full time in the OR.

2. The file for one of the nurses documented prior work experience in pediatric home health, work as an licensed practical nurse (LPN) in medical-surgical nursing and work as "office staff." There was no documentation of previous experience in the OR or in the recovery room.

The file contained signed job descriptions from May 2013 for a recovery room nurse and also for an OR circulator.

3. There was no documentation of orientation and training for the OR or recovery room. There was no verification of skills competencies for these positions. There was a self-evaluation skills checklist dated 03/06/13.

4. The file for the other full-time registered nurse (RN) working as a circulator had a skills checklist completed by an RN evaluator. The checklist, signed on 06/19/13, documented the RN needed "theory and/or practice" or "update and policy review" in forty separate tasks including:

arranging a back table
knowledge of cold disinfectants/sterilants use
preparation of instruments, packs and equipment for surgical procedures
safe operation of equipment
knowledge of basic areas of surgery including, gynecology, basic general cases and basic laparoscopy
crash cart
blood administration
wound drains
restraints
endoscopes
monitoring IV sedation
pediatric anesthesia cart
implant logs
autosuture and staple devices

There was no documentation in the file that indicated the RN had been re-evaluated for competent practice.

The personnel file for this nurse documented six years of experience as a circulator. There was no documentation in the file this prior work expereience was verified at the time of employment.

Based on staff interview and record review, it was determined the hospital failed to maintain a roster of practitioners with surgery privileges.

On 09/25/13, the surgery manager was asked to provide the surveyors with the operating room (OR) department's roster of medical staff with surgery privileges.

She stated the department did not have a current roster.

Based on policy and procedure review, observation and staff interview, it was determined the hospital failed to develop, implement, and enforce surgical policies and procedures based on current nationally recognized standards.

Findings:

1. On 09/25/13 and 09/26/13, surgery policies and procedures were reviewed. None of the policies referenced State or Federal regulations. There was no documentation the policies were based on professional organization standards and recommendations.

2. Some of the policies were not applicable to the hospital and did not reflect current practices.

3. The hospital did not have current policies as required including:

current sterilization and disinfection procedures
aseptic and sterile surveillance and practice
pre-operative work-up
patient consents
clinical procedures and protocols
safety practices unique to the OR
patient identification
staff duties and responsibilities, lines of authority
surgical counts
case scheduling and staff scheduling
personnel policies unique to the OR, including attire, restriction from duty, etc.
emergency procedures unique to the OR
DNR status
handling and processing of surgical specimens
malignant hyperthermia
handling infectious waste
outpatient care planning, coordination and provision of follow-up care.

3. There was no documentation the staff were trained on surgery policies and procedures.

4. The surgery manager stated she was working on policy revisions but they were not complete.

Based on observation, policy and procedure review and staff interview, it was determined the hospital failed to provide all the required emergency equipment for the operating room (OR).

Findings:

On 09/25/13, observations were made of the operating room's crash cart. The cart was not secured in a manner to ensure integrity of the contents.

The OR manager was asked if the department had a list of the current contents of the crash cart. She stated there was no list.

She was asked if she was familiar with the contents of the crash cart. She stated she was not. She stated the OR staff never opened the cart.

The defibrillator on the crash cart had no documentation it had been inspected and tested.

The OR manager stated she did not know if the department had a tracheotomy set.

Based on observation and staff interview, it was determined the hospital failed to provide post-operative care within acceptable standards of practice.

Findings:

1. The recovery room was not located in a separate area of the hospital. The recovery room was located within the surgical suite.

2. Access to the recovery room was not restricted. The room was used by physicians as an examination and treatment area for outpatients. The staff stated sometimes physicians used the recovery room for post-operative doctor visits.

3. The hospital had not developed policies and procedures specific to the recovery room. There was no policy that addressed transfer requirements to and from the recovery room.

4. The clinical record for patient #19 indicated the patient was in the recovery room only 45 minutes after receiving general anesthesia for abdominal surgery. The patient was discharged from the recovery room to his home.

The recovery nurse did not document the patient met discharge criteria including voiding, tolerating liquids, and the application of a support device before discharge.

The recovery nurse did not document the amount of IV fluid the patient received while in recovery or when the IV was discontinued. The nurse did not note the post-operative orders.

There was no documentation of discharge instructions provided by the recovery nurse, including dressing and wound care instructions. There was no documentation of who drove the patient home.

5. The clinical record for patient #22 documented the patient experienced respiratory distress after a procedure. The patient was given a breathing treatment in the recovery room. There was no documentation of a nursing assessment upon admission to the recovery room, during the breathing treatment and no documentation of a nursing assessment after the treatment.

6. The clinical record for patient #21 documented the patient had an abdominal procedure. The recovery nurse did not document discharge instructions, including dressing and wound care instructions.

7. A skills checklist for an registered (RN) who provided post-anesthesia care was signed by an RN evaluator with no documented recovery experience. The checklist documented the RN required more training, knowledge and practice with:

central venous monitoring
EKG
ventilators
epidurals
spinal anesthesia
laryngospasm
blood administration

There was no documentation the RN was re-evaluated for competency.

The personnel file for the RN had no documentation of prior recovery room experience.

Based on document review and staff interview, it was determined the hospital failed to maintain an operating room register with all the required elements.

Findings:

On 09/25/13, the operating room (OR) register was reviewed. The register did not document the patient's age. The register did not document the title of anesthesia providers and of surgical assistants present in the operating room.

The register was not always complete. There were multiple gaps in documentation.

The OR staff stated they were not aware of the requirements for the register.

Based on clinical record review, policy and procedure review, personnel record review and staff interview, it was determined the hospital failed to ensure emergency care was provided to patients in accordance with acceptable standards of practice.

Findings:

a. The hospital failed to ensure emergency services were under the direction of a qualified member of the hospital's medical staff. See A Tag 1102.

b. The hospital failed to ensure the emergency department policies and procedures were approved by medical staff. See A Tag 1104.

c. The hospital failed to ensure the emergency services personnel requirements were met. See A Tag 1110.

d. The hospital failed to ensure the emergency department had been supervised by a qualified member of the medical staff. See A Tag 1111.

e. The hospital failed to ensure staff working in the emergency department had demonstrated skills competencies. See A Tag 1112.

Based on document review and staff interview the hospital failed to ensure emergency services are under the direction of a qualified member of the hospital's medical staff.

Findings:

1. During all three days of the survey, surveyors asked staff to identify the medical director of the emergency department (ED).

On the afternoon of 09/25/13, Staff X told surveyors, "I don't know." Staff Z stated, "That is a good question."

On the morning of 09/26/13, Staff EE informed surveyors, "I am new to the department and don't know."

On the afternoon of 09/26/13, the Chief Nursing Officer (CNO) stated, "I am thinking [physician name omitted] might be the medical director but I will have to check."

2. On the afternoon of 09/25/13, hospital administrative staff provided organizational chart which did not list an ED medical director.

Based on document and staff interview, it was determined the hospital failed to ensure the emergency department policies and procedures were approved by the medical staff.

Findings:

1. On the morning of 09/25/13, the surveyors requested policies and procedures for the hospital's emergency services.

2. On the afternoon of 09/25/13, hospital administrative staff brought the emergency department (ED) policy and procedure manual to the surveyors.

3. On the afternoon of 09/26/13, the chief nursing officer (CNO) told surveyors, "That their policies and procedures don't make sense and are in the process of fixing them."

4. The ED policies did not contain evidence of review, revision and or approval by appropriate staff.

5. Medical staff meeting minutes for 2013 had no documentation that medical staff approved the emergency department policies and procedures.

Based on hospital document review, personnel record review, and interview, the hospital failed to ensure emergency service personnel requirements were met. This occurred for four (Staff V, X, Z, and EE) of four staff files reviewed. On the afternoon of 09/26/13, Staff C verified that all personnel files were complete.

Based on hospital document review and staff interview, it was determined the hospital failed to ensure the emergency department (ED) had been supervised by a qualified member of the medical staff.

Findings:

1. On the afternoon of 09/25/13, hospital administrative staff provided an organizational chart which did not list an ED medical director and it did not list a designated medical staff member to supervise the ED.

2. The Chief Nursing Officer (CNO) verified this with surveyors at the time of review.

Based on hospital document review, record review, and staff interview, it was determined the hospital failed to ensure staff working in the emergency department (ED) had demonstrated skills competencies. This occurred for four (Staff V, X, Z, and EE) of four staff files reviewed.

Findings:

1. Staff training and education files were reviewed for evidence of demonstrated skills competencies for specialized tasks performed in the emergency room:

-Triage Assessment using the emergency severity index (ESI) based on Emergency Nurses Association (ENA) and Agency for Healthcare Research and Quality (AHRQ) guidelines;

-Intravenous (IV) insertion, accessing/de-accessing implanted central venous devices, venous blood draw sampling, and blood glucose monitoring using the Association for Vascular Access (AVA) guidelines;

-Respiratory treatments, assessing, performing, and documentation based on American Association for Respiratory Care (AARC) guidelines;

-Accessing, assembling, and delivering oxygen cylinders with regulators for patient use based on American Association for Respiratory Care (AARC) guidelines;

- Electrocardiogram (ECG) 12 lead cardiac monitoring and rhythm recognition based on the American Heart Association guidelines;

-Neurological assessment using Glasgow coma scale (GCS) based on the ENA;

-IV conscious sedation, rapid sequence intubations (RSI), and airway management based on American Society of Anesthesiologists guidelines;

-Calculating and managing critical IV drips;

None of the records had documentation of verification of skills competencies related to specialized tasks in the ED.

2. On the afternoon of 09/25/2013, Staff X told surveyors the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

3. On the morning of 09/26/13, Staff O and Staff P stated the hospital had not provided skills competency training and had not performed competency testing for nursing staff that worked in the ED.

4. The Chief Nursing Officer (CNO) was asked if the hospital required ED skills competency training. She stated, "They should have received training at hospital orientation."

5. Hospital emergency department policy titled, "Inservice Education" documented, "...educational inservices for maintaining a high level of quality care given to patients presenting to the Emergency Department. Attendance at inservice education classes is mandatory for personnel in the Emergency Department ...The hospital administration shall assure that there are opportunities ..." None of the records had documentation of verification of educational in service training

On the afternoon of 09/26/13, Staff C verified that all personnel files were complete.

Based on review of hospital documents and interviews with hospital staff, the hospital failed to appoint/designate a physician, with knowledge, experience and capabilities to supervise and administer the service properly, to be the director of respiratory care services for the hospital.

Findings:

Review of the hospital's department head list and meeting minutes did not have evidence that a physician had been designated as director of respiratory services.

On the afternoon of 9/26/13, Staff N stated Staff V is the director of the respiratory department. Staff V is a registered nurse, who is the Chief Nursing Officer and Director of the Emergency Department.

Based on review of hospital documents, personnel files and interview with staff, the hospital failed to ensure that respiratory services/procedures were administered by trained staff with each respiratory therapy procedure performed by each employee designated in writing, including the amount of supervision required when performing each procedure.

Findings:

According to the respiratory therapist, nursing staff administered respiratory therapy treatment to patients between 3:00PM and 6:30AM.

Four of four (K, L, V, and X) nursing personnel files reviewed did not contain respiratory competency verification completed by the respiratory therapist as required.

The respiratory therapist on duty on the morning of 09/27/13 stated he did not confirm competency by observation.